Automated Assay Quantitatively Detects Hepatitis B Virus DNA

A test has been approved that provides a fully automated solution for the quantitative detection of Hepatitis B virus (HBV) DNA in human plasma or serum for patients on HBV antiviral therapy. The assay uses a educed sample input volume of 650 mL of either serum or plasma specimens and is standardized against the International standard for hepatitis B. This test is designed for and made by Roche Molecular Diagnostics (Pleasanton, California, USA; www.roche-diagnostics.us), to use on their automated COBAS AmpliPrep/COBAS TaqMan System. The COBAS AmpliPrep / COBAS TaqMan HBV Test v2.0 has been validated to quantify diverse samples from genotypes A-H and pre-core mutants across a broad linear dynamic range of 20 IU/mL to 1.7m 108 IU/mL.